[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR21.65]

[Page 238]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 21--PROTECTION OF PRIVACY--Table of Contents
 
                          Subpart F--Exemptions
 
Sec. 21.65  Access to records in exempt systems.

    (a) Where a Privacy Act Record System is exempt and the requested 
records are unavailable under Sec. 21.61, an individual may nevertheless 
make a request under Sec. 21.40 for notification concerning whether any 
records about him exist and request access to such records where they 
are retrieved by his name or other personal identifier.
    (b) An individual making a request under paragraph (a) of this 
section;
    (1) May be given access to the records where available under part 20 
of this chapter (the public information regulations) or the Commissioner 
may, in his discretion, entertain a request under any or all of the 
provisions of Secs. 21.40 through 21.54; and
    (2) Shall be given access upon request if the records requested are 
subject to 5 U.S.C. 552a(k)(2) and not to 5 U.S.C. 552a(j)(2) (i.e., 
because they consist of investigatory material compiled for law 
enforcement purposes other than criminal law enforcement purposes) and 
maintenance of the records resulted in denial to the individual of any 
right, benefit, or privilege to which he would otherwise be entitled by 
Federal law, or for which he would otherwise be eligible. An individual 
given access to a record under this paragraph (b)(2) is not entitled to 
seek amendment under subpart E of this part. The FDA may refuse to 
disclose a record that would reveal the identity of a source who 
furnished information to the Government under a promise of 
confidentiality, which must be an express promise if the information was 
furnished on or after September 27, 1975. Any individual refused access 
to a record that would reveal a confidential source shall be advised in 
a general way that the record contains information that would reveal a 
confidential source.
    (c) The Commissioner shall not make available any record that is 
prohibited from public disclosure under Sec. 20.82(b) of this chapter.
    (d) Discretionary disclosure of a record pursuant to paragraph 
(b)(1) of this section shall not set a precedent for discretionary 
disclosure of a similar or related record and shall not obligate the 
Commissioner to exercise his discretion to disclose any other record in 
a system that is exempt under Sec. 21.61.

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